Effects of Dual-Task Training in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Effects of Dual-Task Training on Balance, Gait, Dual-Task Performance, Cognitive Function, Fatigue in People With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526287
• Other study ID #: MOzkeskin
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: March 2023
• Source: Ege University
• Contact: Mehmet OZKESKIN, PhD
• Phone: +905056631833
• Email: mehmet.ozkeskin99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of dual task training on balance, gait, dual-task performance, cognitive function, fatigue and functional mobility in people with Multiple Sclerosis(MS).

Description:

Eligible participants will be randomized to dual-task group or control group. Dual-task group will receive 8 weeks of dual-task training twice a week and home exercise program. Control group will receive only home exercise program for 8 weeks. Each participant will be assessed before and after the 8 weeks of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: August 15, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having a definitive diagnosis of MS according to the revised McDonald criteria
• Having Expanded Disability Status Scale score between 0-5.5
• No relapse in the last 30 days
• Having a Mini Mental Test score of 24 and above
• Being fluent in Turkish language
• No condition that prevents exercising

Exclusion Criteria:

• Being pregnant
• Presence of a neuro-musculoskeletal disease other than Multiple Sclerosis
• Having received physiotherapy for balance and gait disorders in the last 3 months

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Dual-Task Training
Dual-task training sessions include; walking on treadmill for 10-30 minutes and half of this walking period participants will perform cognitive tasks, cognitive tasks will be repeated on tandem stance position and single leg stance position other half of the session consists of motor-motor dual task activities and gait training on firm and soft surfaces. Home exercise program includes lower extremity, core stability and balance exercises and will be performed three times a week.
• Home Exercise Program
Home exercise program includes lower extremity, core stability and balance exercises and will be performed three times a week.

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Health Sciences	Izmir	Karsiyaka

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale(BBS)	BBS, evaluates daily activities including static sitting and standing balance, as well as transfers, turning, and picking up objects from the ground, in 14 items.Scoring is given as 0-4. It scores from 4 (normal performance) to 0 (not able to do the movement) according to the person's ability to do what is asked of them safely and independently. The total score is 56 points. 0-20 indicates high risk, 21-40 indicates medium risk, and 41-64 indicates low risk.	eight weeks
Primary	Timed Up And Go Test (TUG)	It is a frequently used test that evaluates functional mobility and dynamic balance. At the beginning of the test, individuals sit in a chair. A distance of 3 m is set in front of the patient. With the start command, the patient gets up from his seat and walks 3 m, turns around and walks back and sits. With the start command, the time until the moment of sitting on the chair is recorded in seconds.Shorter duration indicates better functional mobility.	eight weeks
Primary	Tetrax((Sunlight Medical Ltd, Israel),Computerized Static Posturography Device	Tetrax (Sunlight Medical Ltd, Israel) computerized posturography device consists of a platform system where data is collected, a computer and software system where data is processed and integrated. Participants will stand on the platform system in 8 different condition. Tetrax will be used to measure static balance and fall risk.	eight weeks
Secondary	MS Walking Scale-12(MSWS-12)	MSWS-12 is a 12-item scale evaluating the effect of MS on person's walking ability. MSWS-12 is scored between 12-54. Higher scores indicate more negatively affected walking ability.	eight weeks
Secondary	Fatigue Severity Index(FSI)	The scale consists of 9 questions and each question is graded over 7 points.FSI is scored between 0-63. Higher scores indicate more fatigue.	eight weeks
Secondary	Brief International Cognitive Assesment for MS(BICAMS)	BICAMS includes Symbol Digit Modalities Test (SDMT), California Verbal Learning Test II (CVLT-II) and Brief Visuospatial Memory Test-Revised (BVMT-R). The total score is determined by summing the scores of the 3 tests. Battery will be used to evaluate cognitive function. Higher scores indicate better cognitive function.	eight weeks
Secondary	10 Meter Walking Test(10MWT)	This test calculates the unassisted walking speed of individuals at a distance of 10 meters. In this test, the person will be asked to walk at their normal pace in a pre-measured 10 meter area.	eight weeks
Secondary	Dual-Task Performance	Dual-Task performance will be measured with TUG-cognitive and 10MWT-motor. In TUG-cognitive,patient will be counting down by three from a number between 100 and 200 while performing Timed-Up and Go test. In 10MWT-motor,patient will be carrying a tray with 3 water filled 200 ml plastic glasses while walking a 10 m distance.Time will be measured. Longer time to complete task indicates lower dual-task performance.	eight weeks
Secondary	Dual-Task Questionnaire(DTQ)	The Dual Task Questionnaire assesses the frequency of difficulties experienced by individuals with neurological injury or disease during activities of daily living that involve dual tasks. DTQ is scored between 0-40. Higher scores indicate more frequent dual-task difficulties.	eight weeks